Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone

Other Complications Associated With Artificial Fertilization Clinical Trial

Official title:

Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01291212
• Other study ID #: FIV-01
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2011
• Last updated: February 7, 2011
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2011
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.

Description:

Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients.

There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

Inclusion Criteria:

• Low responder patients: patients with previously canceled cycle or recovery of 3 or less oocytes

Exclusion Criteria:

• FSH > 12

• Previous ovarian surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Other Complications Associated With Artificial Fertilization

Intervention

Drug:
• Testosterone and FSHr-LHr
75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
• testosterone and FSHr alone
FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Balasch J, Fábregues F, Peñarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. Epub 2006 Mar 3. — View Citation

Fábregues F, Peñarrubia J, Creus M, Manau D, Casals G, Carmona F, Balasch J. Transdermal testosterone may improve ovarian response to gonadotrophins in low-responder IVF patients: a randomized, clinical trial. Hum Reprod. 2009 Feb;24(2):349-59. doi: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovarian response	number of oocytes obtained per ovarian stimulation cycle	within 2 weeks after begining ovarian stimulation	No
Secondary	clinical pregnancy rate	The number of clinical pregnancies expressed per embryo transfer cycles. Clinical pregnancy: a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Multiple gestational sacs are counted as one clinical pregnancy.	within 5 weeks (plus or minus 1 week) after embryo transfer	No
Secondary	Implantation rate	The number of gestational sacs (observed by ultrasound examination) divided by the number of embryos transferred.	within 5 weeks (plus/minus 1 week) after embryo transfer	No
Secondary	Live birth rate	The number of deliveries that resulted in at least one live born baby expressed per 100 embryo transfer cycles.	within 9 months (plus/minus 1 month) after embryo transfer	No